Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00316719

First received: April 19, 2006

Last updated: October 1, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 19, 2006

Last Updated Date

October 1, 2009

Start Date ^ICMJE

January 2006

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in serum HBV-DNA level from baseline to week 52

Change History

Complete list of historical versions of study NCT00316719 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Time to Onset of HBV DNA Loss (< 400 Copies/mL) [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Time to Onset of HBeAg Loss [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
Time to Onset of HBeAg/Ab Seroconversion [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Mean Alanine Aminotransferase (ALT) Level at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Time to Onset of ALT Normalization [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
Rate of Emergence of Resistant Virus at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Evaluation of HBV-DNA level and other virus markers at week 52
ALT level and proportion of patients achieving ALT normalization at week 52,and time to onset of confirmed serum ALT normalization.
Emergence rate of resistant virus

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

Official Title ^ICMJE

Phase III Study of Adefovir Dipivoxil Tablets in Patients With Compensated Chronic Hepatitis B -Comparative Study Against Lamivudine-

Brief Summary

This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Hepatitis B

Intervention ^ICMJE

Drug: LAM group
Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.

Other Name: Lamivudine
Drug: ADV group
Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.

Other Name: adefovir dipivoxil

Study Arm (s)

Experimental: Adefovir Dipivoxil (ADV)
Intervention: Drug: ADV group
Active Comparator: Lamivudine (LAM)
Intervention: Drug: LAM group

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

105

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Have compensated chronic hepatitis B.
Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
Ability to read, understand, and sign the informed consent.
Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L

Exclusion criteria:

Having or suspected of having liver cancer.
Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
Autoimmune hepatitis.
Received any previous transplantation or having a plan for any transplantation.
Existence of any serious complication, except hepatitis B.

Gender

Both

Ages

16 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00316719

Other Study ID Numbers ^ICMJE

ADF105220

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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